Hello Fellow Blood Bankers.  I was hoping someone....anyone could help me understand.  We have an inspector who is telling us that biannually we need to compare the results of our tube IS crossmatch with our gel AHG crossmatch.  Firstly, we never run an AHG crossmatch without a tube IS since the gel has not been validated to detect ABO incompatibility.  Secondly, I am having a hard time understanding how the two will correlate given that they dont typically detect the same type of antibodies.   I understand that you  need to do this for same tests that are performed on different testing platforms but I guess I never thought this was necessary.  Do you do this at your laboratory?  How do the results correlate for you?

 

Thanks in advance!

Personally, I think this inspector is completely over the top, and I agree with you that they are not designed to test the same type of antibodies.

 

You could be really sarcastic, as would I, by telling him or her that you have correlated these techniques, by the fact that all of your patients had survived the transfusions following the use of the techniques!

I agree; this inspector is confused.  I could see if you perform tube AHG and gel AHG crossmatches, you would be correlating the methods.  But you can't correlate the IS to the AHG.

The same inspector is saying that the Blood Bank Medical Director has to review all BB QC.  I understand that he has to oversee processes and procedures, but to review the actual  QC?  I have worked in 3 hospitals and never seen this.  Does anyone know if that is actually something that needs to be done? Thanks again- These guys are coming up with things I have never heard of or seen in 11 years in BB.  She also said that in addition to the state licencse for Bone and tissue from all our vendors and the FDA reg we have to have a company cover letter.  I can't find it any reg.  I am really starting to think they are just making things up.

I've had some inspectors that get really subjective on the standards and I always ask to call CAP "as a referee" or to get clarification of the standard - most of the time they are able to sort it out over the phone! When in doubt challenge the very same day they are questioning you. Sounds to me like your inspector is trying to understand the intent of the standard but may not be a practicing blood banker or they would know comparing IS XM to IgG crossmatch is not method correlation - I'd show them the technical manual in which explains the definitions of the two types of crossmatches and what they are used for - then hopefully the inspector would understand it's like comparing apples to oranges versus gala apples to golden crisp apples (for example gel AHG XM vs tube AHG XM for which the standard is intended).

 

Just to cover ourselves as far as QC review goes - we wrote in our policy that QC is reviewed and passed and marked down on the daily maintenance record sheet and the medical director signs off on that sheet on a monthly basis - so the Medical Director is essentially reviewing that QC passes on a daily basis. If there was ever a QC failure, we have a seperate procedure for corrective action to document what we did to troubleshoot and when QC ultimately passed and the medical director signs off on all corrective actions documents as well. So maybe that might help for the future. It's absurd that the MD would have to look at every QC reaction on a daily basis!

Good luck!

Inspector from what agency? TJC, CAP, AABB, FDA, STATE, CLIA? Did I miss any?

Edited November 12, 201410 yr by tricore

I thought I remember QC review being the medical director's responsibility but it was generally designated to another individual. Lead, supervisor, etc.

This happens to be a TJC inspection.  I challenged the citation this morning- I still couldnt understand what she was getting at.   I am at the core lab and she was inspecting one of our 3 off site laboratories.  I will have a different inspector and hopefully we will be able to see eye to eye on this.

This does sound odd.  When we have a disagreement with an inspector, we have two options -- arguing it out on the spot --(usually no point -- the inspector has already made up their mind or they would not have brought it up) -- or waiting for the report.  The report must list each standard that is being violated. 

 

Like others here, I have never heard of, and cannot imagine, a BB standard that requires what your inspector is asking for.  Have they provided you with a daily preliminary report that you can check the standard against?

 

Good luck.

 

Scott

Call TJC and tell them your inspector does not comprehend transfusion service testing and request a different inspector. 

I managed to talk my way out of 4 non-comformancies at my first audit. If you know your stuff and you can explain to them why they are wrong, you can get it dropped on the spot. You do have to be good at debate though...

 

My idiot one was they complained that we hadn't validated the boxes we were using. We had been using temperature loggers in the boxes for 2 years, documenting the temperature every 5 minutes and argued the fact that there had only been one failure in 2 years (due to the air con on the van breaking down when the temps were at minus 16 and them getting stuck in snow for 10 hours) that it was a self validating system. We compromised and I agreed to rotate the boxes to a shedule to ensure they were getting monitored equally. I suppose they had to pull us for something...

 

I would argue in this case that comparing a technology detecting IgA and one detecting IgG is like comparing a platelet count to a FBC - lunacy!

Call TJC and tell them your inspector does not comprehend transfusion service testing and request a different inspector. 

 

I was actually tempted to say this! 

Well we had 2 inspectors.  I talked to both of them separately and eventually the one at our off sites dropped it.  I just dont think she was understanding that they never do full tube crossmatches and we dont use buffered gel cards at our off sites, only at the core lab.  We did get a citation for no pathologist review of our QC but she said we can make a summary page and he can sign off on that.  Over the weekend I remebered when we had a CMS validation survey for DOH about 6 years ago the surveyor asked if we had a QC failure, would we notify the medical director etc.  but they didnt say he had to actually sign off on anything.  Oh well.  Seems like an easy fix.   Thank you for all of your comments and suggestions.  I thought I was going crazy there for a minute and all of your knowledge and expertise was much appreciated!

We are TJC inspected also.  We have been doing method comparisons between gel and tube.... but we are testing antibody ID, not crossmatches.  We have had some anti-E and Kidds that were detected in gel, but not in tube.  We make a statement about the gel methodology being more sensitve than tube and several different inspectors have been ok with that. 

 

At first we were just doing the comparisons randomly throughout the year as we had:

1.  patients with different antibodies at our facility  (not an E or a K!)

2.  these patients had specimens that had excess sample available for tube testing

3.  the need to complete competency testing of staff

4.  time available for a different staff member to do the testing

 

On our last inspection we were told to aim for making it two distinct studies over the course of the year.  This has resulted in less variety of our antibodies tested!

I agree that gel IAT is usually more sensitive than tube IAT, but we have recently had an anti-Fy^a that reacted by tube IAT, but simply refused to work at all by gel IAT.

 

I am no longer surprised at anything!

The medical director can delegate (in writing, we have an SOP) QC review.

The same inspector is saying that the Blood Bank Medical Director has to review all BB QC.  I understand that he has to oversee processes and procedures, but to review the actual  QC?  I have worked in 3 hospitals and never seen this.  Does anyone know if that is actually something that needs to be done? Thanks again- These guys are coming up with things I have never heard of or seen in 11 years in BB.  She also said that in addition to the state licencse for Bone and tissue from all our vendors and the FDA reg we have to have a company cover letter.  I can't find it any reg.  I am really starting to think they are just making things up.

A little of the main subject: I was recently inspected by CAP and the inspector mentioned that I should be doing an extended XM not only with my IgG card, but also with  buffer cards. Our current process for the extended/full XM is to perform the IS by tube and we have the option to perform the AHG by tube or gel using anti-IgG. She mentioned something about reactions at 37 degrees in tube = AHG XM reactions with buffer cards.

She could not find any sustaining evidence and she left it as a recommendation. Does anyone practice the technique she mentioned? or the technique I currently use?

 

-Thanks

I'm under the impression that the buffered gel cards were a means of detecting ABO incompatibility - replacement for immediate spin tube technique for laboratories that were trying to get rid of tube testing.

We have been with Joint Comm (TJC) for 2 years now.  They said that with their standards, the Lab Medical Director has to sign all new and revised Blood Bank procedures and has to do the SOP review every year too, for Blood Bank only.  The other depts are delegated to other pathologists and lab supervisors, but not Blood Bank.  They would not even accept the pathologist who has oversight of the Blood Bank because she is not the acting Medical Director.  That was a change from what we had been doing with CAP.

 

I also have the pathologist with responsibility over Blood Bank, review and sign off on my QC work at the end of each month.  The FDA said it had to be someone other than me and they were not happy with another supervisor either, so she wound up with it.  Joint (TJC) seems happy with that SOP too.